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Medical Writing

2-4 years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here’s the rewritten job description with a unique slug at the end:


Medical Writing Role – TCS, Mumbai

📍 Location: Mumbai
📅 Experience: 2 - 4 years
📅 Apply By: 21-Mar-2025

Job Description:

Tata Consultancy Services (TCS) is hiring for a Medical Writing role!

Key Responsibilities:

  • Define, discuss, and align document expectations during kickoff and follow-up meetings.
  • Lead the authoring and editing of clinical documents in compliance with regulatory guidelines and industry standards.
  • Ensure adherence to established processes, timelines, and document formatting guidelines.
  • Conduct quality reviews of clinical documents within set timelines, ensuring compliance with templates and guidelines.
  • Communicate effectively with internal and external stakeholders, including authors and key opinion leaders, to resolve content-related issues.
  • Stay updated on project status, clinical operating plans, ongoing/new studies, and relevant scientific literature.
  • Maintain and develop expertise in regulatory guidelines, technological advancements, and industry best practices.
  • Train and mentor new and existing medical writers, guiding them through live projects.

Additional Responsibilities (Documentation Lead Role, if assigned):

  • Lead PDRD deliverables and act as the primary point of contact for document preparation.
  • Ensure consistency and content reuse across documents for a given product.
  • Guide lead document writers on content alignment and timelines.
  • Provide necessary source documents, study documentation details, and key project contacts.
  • Actively participate in Regulatory Affairs and cross-functional team meetings.
  • Review document content before finalization to ensure high quality before expert or author review.

Desired Candidate Profile:

Qualifications:

  • Bachelor’s Degree: Pharmacy (B.Pharm), Science (B.Sc)
  • Master’s Degree: Science (M.Sc), Applied Physics (M.Sc Applied Physics)

📌 Job Function: Business Process Services
📌 Role: Executive